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URSOBILANE 500 mg CAPSULES

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About the medicine

How to use URSOBILANE 500 mg CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Patient Information Leaflet

Ursobilane 500 mg capsules

Ursodeoxycholic acid

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What Ursobilane 500 mg capsules are and what they are used for
  2. What you need to know before you take Ursobilane 500 mg capsules
  3. How to take Ursobilane 500 mg capsules
  4. Possible side effects
  5. Storing Ursobilane 500 mg capsules
  6. Contents of the pack and further information
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1. What Ursobilane 500 mg capsules are and what they are used for

The active substance in Ursobilane 500 mg capsules is ursodeoxycholic acid, which belongs to a group of medicines called bile stone dissolvers.

It is used to dissolve cholesterol gallstones, provided they are radiotransparent and the gallbladder is functioning (which should have been verified by a test called oral cholecystography). Ursobilane is also used to treat a rare disease of the bile ducts and liver called primary biliary cirrhosis.

2. What you need to know before you take Ursobilane 500 mg capsules

Do not take Ursobilane 500 mg capsules

  • If you are allergic to ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6).
  • If you have a stomach or duodenal ulcer.
  • If you have a non-functioning gallbladder.
  • If you have calcified cholesterol stones, radio-opaque stones, or radiotransparent bile pigment stones.
  • If you have liver or intestinal disorders that may interfere with the circulation of bile salts.
  • If you are breastfeeding.

Warnings and precautions

Consult your doctor before taking Ursobilane 500 mg capsules:

  • If you are taking medicines that may cause a buildup of cholesterol in the bile, such as estrogens and hormonal contraceptives.
    • If you are being treated with medicines that may be toxic to the liver.

During treatment with Ursobilane 500 mg capsules, your doctor will perform tests to monitor your liver function.

Children and adolescents

The safety and efficacy of Ursobilane in children have not been established, so its use is not recommended in this population.

Other medicines and Ursobilane 500 mg capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ursobilane 500 mg capsules may interact with other medicines such as:

  • Antacids containing aluminum.
  • Cholestyramine or colestipol, or other medicines for treating high cholesterol.
  • Antibiotics: neomycin.
  • Hormonal contraceptives, such as estrogens or progestogens.

Taking Ursobilane 500 mg capsules with food, drinks, and alcohol

It is preferable to take the medicine with meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take this medicine while breastfeeding.

Driving and using machines

Ursobilane 500 mg capsules have no effect on the ability to drive or use machines.

Ursobilane 500 mg capsules contain the yellow-orange S dye (E-110)

This medicine may cause allergic reactions because it contains the yellow-orange S dye (E-110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Medicine questions

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3. How to take Ursobilane 500 mg capsules

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Ursobilane 500 mg capsules are only administered to adults.

The capsules should be swallowed whole, without chewing, with a little liquid. If you have difficulty swallowing, you can disperse the powder contained in the capsules in a liquid.

Take Ursobilane 500 mg capsules preferably with meals.

The recommended dose for the treatment of gallstones is 1 capsule per day (8-10 mg/kg/day).

It is essential that you visit your doctor regularly to check the progression of your disease. While taking this medicine, you will need to have laboratory tests every few months to check that the gallstones are dissolving and that your liver is functioning correctly.

The recommended dose for the treatment of primary biliary cirrhosis is 2 capsules per day (13-15 mg/kg/day), divided into several doses.

Your doctor will advise you to follow a moderate calorie and cholesterol diet during treatment with Ursobilane 500 mg capsules.

If you take more Ursobilane 500 mg capsules than you should

The most common symptom of an overdose of Ursobilane 500 mg capsules is the appearance of diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ursobilane 500 mg capsules

Do not take a double dose to make up for forgotten doses.

If you stop taking Ursobilane 500 mg capsules

Do not stop treatment without consulting your doctor, as the expected effect will not be achieved.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined below:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

Very rare: may affect up to 1 in 10,000 people.

Frequency not known: frequency cannot be estimated from the available data.

Gastrointestinal disorders

Rare:nausea and vomiting, difficulty digesting, alterations in taste, biliary pain, abdominal pain, feeling of gas, and constipation.

Very rare:diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ursobilane 500 mg capsules

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ursobilane 500 mg capsules

The active substance is ursodeoxycholic acid. Each capsule contains 500 mg of ursodeoxycholic acid.

The other excipients are magnesium stearate, powdered cellulose, colloidal silica, and sodium carboxymethyl starch (type A) (from potato).

The components of the capsule are: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), yellow-orange S (E-110), and indigo carmine (E-132).

Appearance and packaging

Green and orange capsules.

Aluminum-PVC/PVDC blister packs containing 60 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona - Spain

Manufacturer

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona - Spain

You can request more information about this medicine from the local representative of the marketing authorization holder:

Laboratorio Aldo-Unión, S.L.

C/Baronesa de Maldá, 73

08950 Esplugues de Llobregat

(Barcelona) Spain

Date of last revision of this leaflet:January 2012

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

Online doctors for URSOBILANE 500 mg CAPSULES

Discuss questions about URSOBILANE 500 mg CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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General internal medicine and preventive care:
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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

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Frequently Asked Questions

Is a prescription required for URSOBILANE 500 mg CAPSULES?
URSOBILANE 500 mg CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in URSOBILANE 500 mg CAPSULES?
The active ingredient in URSOBILANE 500 mg CAPSULES is ursodeoxycholic acid. This information helps identify medicines with the same composition but different brand names.
How much does URSOBILANE 500 mg CAPSULES cost in pharmacies?
The average pharmacy price for URSOBILANE 500 mg CAPSULES is around 24.74 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures URSOBILANE 500 mg CAPSULES?
URSOBILANE 500 mg CAPSULES is manufactured by Laboratorio Estedi S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of URSOBILANE 500 mg CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether URSOBILANE 500 mg CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to URSOBILANE 500 mg CAPSULES?
Other medicines with the same active substance (ursodeoxycholic acid) include URSODESOXYCHOLIC ACID GRINDEKS 250 mg HARD CAPSULES, ADISOCOL 150 mg TABLETS, ADISOCOL 250 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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